The FDA has identified this as a Class I recall, the most serious type of recall and use of these devices may cause serious injuries or death.
Boston Scientific is recalling INGENIO family of pacemakers and CRT-Ps due to the risk of transitioning to safety mode. Safety mode is intended to provide backup if the device is faulty. However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, the device cannot be reprogrammed and must be replaced.
The use of the affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life-threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death.
There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing. There have been no reports of death.